There was a clinically meaningful and persistent improvement depression measured by the key secondary endpoint of MADRS. [1] The primary endpoint of superiority to placebo in a cognitive "attention composite" of three Cogstate computerized tests was not met with large improvements seen in both Xanamem and placebo groups. Xanamem was safe and well tolerated.
SYDNEY , Aug. 12, 2024 /PRNewswire/ -- Actinogen Medical ASX: ACW ("ACW" or "the Company") announces that Xanamem treatment had clinically and statistically significant (p < 0.05) benefits on depression in its phase 2a XanaCIDD trial of Xanamem in patients with cognitive dysfunction and major depressive disorder (MDD).
This outcome indicates potential modification of the underlying biology of depression as a result of inhibition of tissue cortisol synthesis – a completely novel mechanism for the treatment of depression. The trial did not meet the primary endpoint of improving the "Attention Composite" in the context of an unexpectedly large improvement in the placebo group. Key XanaCIDD trial findings and their implications are: Xanamem was safe and well-tolerated with a promising safety profile consistent with prior trials MADRS depression score improvement in all 165 patients favoured Xanamem over placebo.
These clinically significant benefits (Cohen's d (Cd) > 0.2) in change from baseline was observed at the end of 6 weeks of treatment (1.5 points, Cd = 0.
24, p = 0.11) and were statistically significant four weeks aft.